Using colchicine to treat heart failure with preserved ejection fraction
Colchicine in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
This study is testing if colchicine, an anti-inflammatory drug, can help people with heart failure and preserved heart function feel better by reducing inflammation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT05637398 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of colchicine, an anti-inflammatory drug, on patients suffering from heart failure with preserved left ventricular ejection fraction (HFpEF). The study aims to understand how colchicine can reduce inflammation and lower levels of soluble suppression of tumorigenicity 2 (sST2), which is associated with heart failure. Participants will be monitored for changes in their heart function and inflammatory markers. The trial includes both Phase 1 and Phase 2 assessments to evaluate safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 and older with HFpEF, characterized by specific heart function metrics and elevated inflammatory markers.
Not a fit: Patients with conditions such as hypertrophic cardiomyopathy, recent acute decompensation of heart failure, or those with active inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with HFpEF by reducing inflammation and associated heart failure symptoms.
How similar studies have performed: While colchicine has shown promise in other cardiovascular conditions, its application in HFpEF is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 40 years of age, male and female * Left ventricular ejection fraction (LVEF) ≥ 50% * Symptoms and signs of heart failure * N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥300 pg/ml at baseline (patients in atrial fibrillation at baseline NT-proBNP ≥ 600 pg/ml), left atrial volume index (LAVI) \>34 mL/m2 or a left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females * body mass index (BMI) \> 30kg/m2 or diabetes mellitus Exclusion Criteria: * Hypertrophic cardiomyopathy, constrictive pericarditis, or cardiac amyloidosis * Acute decompensation of HF in the last 1 month * Valvular heart disease * Prior history of LVEF below 50% * Acute myocardial infarction in the last 3 months, cardiac surgery or cerebrovascular accident within the recent 6 months * Any active or chronic inflammatory diseases or infections * Patients with indication for colchicine therapy or history of colchicine intolerance * Severe hepatic (alanine aminotransferase N3 upper limit of normal or renal dysfunction (estimated glomerular filtration rate \<45 mL/min per 1.73m2) * Severe nervous system diseases * History of any malignancy or suffering from cancer * Lack of informed consent
Where this trial is running
Moscow and 1 other locations
- A Shchendrygina — Moscow, Russian Federation (Recruiting)
- Anastasia Shchendrygina — Moscow, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Anastasia Shchendrygina — Sechenov Univerity
- Study coordinator: Anastasia SHCHENDRYGINA
- Email: a.shchendrygina@gmail.com
- Phone: +79262309207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.